pemetrexed disodium in treating patients with persistent or recurrent endometrial cancer

Conditions: Endometrial Cancer

Summary: rationale: drugs used in chemotherapy such as pemetrexed disodium work in different ways to stop tumor cells from dividing so they stop growing or die. purpose: this phase ii trial is studying how well pemetrexed disodium works in treating patients with persistent or recurrent endometrial cancer.

objectives: * determine the antitumor activity of pemetrexed disodium in patients with persistent or recurrent endometrial adenocarcinoma that failed higher priority treatment protocols. * determine the nature and degree of toxicity of this drug in these patients. outline: this is a multicenter study. patients receive pemetrexed disodium iv over 10 minutes on day 1. courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. beginning 7 days before and continuing until 3 weeks after the last dose of pemetrexed disodium, patients also receive oral folic acid daily and cyanocobalamin (vitamin b_12) intramuscularly every 9 weeks. patients are followed every 3 months for 2 years and then every 6 months for 3 years. projected accrual: approximately 19-51 patients will be accrued for this study within 1-3.4 years.

Eligibility criteria:
disease characteristics: * histologically confirmed endometrial adenocarcinoma * persistent or recurrent disease * refractory to curative or standard therapy * measurable disease * at least 1 unidimensionally measurable target lesion ≥ 20 mm by conventional techniques, including palpation, plain x-ray, ct scan, or mri or ≥ 10 mm by spiral ct scan * tumors within a previously irradiated field are considered non-target lesions unless progression is documented or biopsy is obtained to confirm persistence ≥ 90 days after completion of radiotherapy * must have received 1 prior chemotherapy regimen for endometrial cancer * initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment * not eligible for a higher priority gog protocol (i.e., any active phase iii gog protocol for the same patient population) patient characteristics: age * any age performance status * gog 0-2 life expectancy * not specified hematopoietic * absolute neutrophil count ≥ 1,500/mm\^3 * platelet count ≥ 100,000/mm\^3 * hemoglobin ≥ 9 g/dl hepatic * ast and alt ≤ 3 times upper limit of normal (uln)\* * alkaline phosphatase ≤ 3 times uln\* * bilirubin ≤ 1.5 times uln note: \* ≤ 5 times uln if liver metastases are present renal * creatinine clearance ≥ 45 ml/min other * not pregnant * negative pregnancy test * fertile patients must use effective contraception during and for at least 3 months after study participation * neuropathy (sensory and motor) ≤ grade 1 * no active infection requiring antibiotics * no other invasive malignancy within the past 5 years except nonmelanoma skin cancer prior concurrent therapy: biologic therapy * at least 3 weeks since prior biologic or immunologic agents for the malignant tumor * one prior non-cytotoxic (biologic or cytostatic) regimen for recurrent or persistent disease allowed, including, but not limited to, the following: * monoclonal antibodies * cytokines * small-molecule inhibitors of signal transduction * at least 24 hours since prior growth factors * no concurrent routine colony-stimulating factors chemotherapy * see disease characteristics * recovered from prior chemotherapy * no more than 1 prior cytotoxic chemotherapy regimen with either single or combination cytotoxic drug therapy * no prior pemetrexed disodium endocrine therapy * at least 1 week since prior hormonal therapy directed at the malignant tumor * concurrent hormone replacement therapy allowed radiotherapy * see disease characteristics * at least 2 weeks since prior radiotherapy and recovered * no prior radiotherapy to ≥ 25% of bone marrow surgery * recovered from prior surgery other * at least 3 weeks since other prior therapy directed at the malignant tumor * no nonsteroidal anti-inflammatory drugs 2-5 days before, during, and for 1-2 days after study drug administration * concurrent daily low-dose (≤ 325 mg/day) aspirin therapy allowed * no prior therapy that would contraindicate study participation

Keywords: recurrent endometrial carcinoma endometrial adenocarcinoma stage iii endometrial carcinoma stage iv endometrial carcinoma